The diagnostic method of the digene HC2 High-Risk HPV DNA Test and the digene HC2 HPV DNA Test (which are collectively called the digene HPV Test) allows rapid, standardized testing of genetic material of the infectious agents in virtually any laboratory setting. It employs specific RNA probes, hybridization, antibody capture, and signal amplification that utilizes qualitative chemiluminescent detection.
The digene HPV Test, using Hybrid Capture 2 technology, provides an accurate, cost-effective, user-friendly method by achieving reliable and reproducible detection.
Benefits of HC2:
- Full-length probe for reliable senstivity and specificity with no risk due to deletions
- Unmatched cervical intraepithelial neoplasia (CIN) 2+ sensitivity
- Same day results in a microplate test format
- High-throughput automation for handling increasing test volumes
- Minimal specimen preparation required for fast and efficient sample processing
- Signal amplification method with reduced cross-contamination risk
- Extensive, clinical validation data available
Back to topClinical sensitivity is critical
For routine HPV diagnostics and clinical decision making, clinical sensitivity is critical. The HC2 technology fulfills this requirement better than any other method as outlined in multiple clinical validation studies. Cervical cancer screening methods require HPV detection correlating to disease and not to the sheer presence of the virus, since 90% of infections is cleared by itself without consequences.
HC2 technology measures sensitivity versus defined clinical endpoints (CIN 3+/SCC) and ensures reporting of positive results only when risk of disease progression exists. QIAGEN’s digene
HPV Test has an excellent clinical sensitivity of up to 100% in primary adjunctive screening when combined with a Pap smear test [Mayrand, M.H., et al. (2007) N. Engl. J. Med. 357(16), 1579.].
- Clinically validated cutoff of 5000 copies/ml
- Proven in extensive multiple trials
- Ensures high negative predictive value
Back to topHow Hybrid Capture 2 technology works
The HC2 System
is a signal-amplification assay that uses a technique combining antibody capture and chemiluminescent signal detection.